Cleared Traditional

MODEL 9000 BARIATRIC WHEELCHAIR

K002317 · Invacare Corp. · Physical Medicine

Aug 2000

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K002317 is an FDA 510(k) clearance for the MODEL 9000 BARIATRIC WHEELCHAIR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on August 25, 2000, 25 days after receiving the submission on July 31, 2000. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K002317 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2000
Decision Date	August 25, 2000
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — General Controls
CFR Regulation	21 CFR 890.3850
Definition	A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets ?mobility To Persons Restricted To A Sitting Position? To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.